FDA Inspection 1239667 — Stony Brook Community Medical PC - Island Fertility
The FDA completed an inspection of Stony Brook Community Medical PC - Island Fertility on May 28, 2024 in Commack, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 28, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Commack, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12229 | 21 CFR 1271.50(a) | Determination based on screening and testing |
| 12232 | 21 CFR 1271.50(b)(2) | Donor testing not negative for CD agents |
| 12272 | 21 CFR 1271.65(b)(2) | Labeled re: biohazard, risks, test results |